EK-Med 3.9-B16 OEM设备的符合性评估(中英文版).pdfVIP

Answers and Resolutions by EK-Med EK-Med （医疗器械条例）解答和决议 P1 Conformity Assessment 合性评估 3.9 B 16 Certification of OEM Devices OEM 设备的认证 Often identical medical devices are placed on the market under different manufacturers names, although a single producer makes them. In such cases the company under whose name the device is placed on the market does not control large parts of the devices design and manufacturing process. Dealers or sales organisations who place medical devices on the market under their own name are, however, manufacturers in the meaning of the Medical Devices Directives and must conduct a corresponding conformity assessment procedure –regardless of what influence they have on the development and/or production of the devices. In such cases the Notified Body will only be able to audit a few aspects of the conformity assessment procedure selected directly at the manufacturers premises in the meaning of the Directives. 很多时候，即使是来自同一生产商的相同医疗器械，在上市时会冠以不同的制造 商名称。在这种情况下，为上市产品提供名称的公司并不控制该产品设计和制造 过程中的大部分环节。但是，根据医疗器械指令定义，这些将医疗器械以其名称 上市的经销商或销售机构，应被称为制造商，并且必须执行相应的符合性评估程 序——无论其对于产品开发和/或生产的影响大小。在这种情况下，公告机构在 符合指令定义的制造商工厂中，只能直接审核到符合性评估程序的几个环节。 If Original Equipment Manufacturers (OEM) carry out relevant design or manufacturing steps, the Notified Body must include these steps in the assessment. This arises from the provisions of Medical Devices Directives. 如果原始设备制造商 OEM）参与了相关设计或制造环节，公告机构必须将这 些环节纳入评估中。这来自医疗器械指令的要求。 The extent to which the OEM is being involved in the conformity assessment procedure for the private label manufacturer (PLM) is mainly dependent on whether and on which basis certificates exist for the OEM respectively his quality management system or products and by which body these certificates were issued. 对于自有品牌制造商 PLM）而言，其OEM在符合性评估程序中的涉及程度， 主要取决于其OEM是否取得证书、该证书是基于质量管理体系亦或产品认证、 甚至于颁发证书的机构。 1 The different possible scenarios are describe